Use of Antiseptic Solution for Vaginal Wash Before Cesarean Section

S

Saint Thomas Hospital (HST)

Status

Completed

Conditions

Endometritis
Operation Wound; Infection

Treatments

Drug: Saline solution
Drug: Clorhexidine

Study type

Interventional

Funder types

Other

Identifiers

NCT03442218
MHST2014-20

Details and patient eligibility

About

To evaluate the rate of infections after cesarean sections in patients with premature rupture of membranes after vaginal wash either with an antiseptic solution (clorhexidine solution) vs. saline solution (placebo).

Enrollment

203 patients

Sex

Female

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Women with gestation between 34 and 41 6/7 weeks.
  • Premature rupture of membranes (> 6 hours).
  • Use of prophylactic antibiotic 1 hour previous to cesarean section.

Exclusion criteria

  • Any source of infection diagnosed previous to surgery.
  • Fever of unknown origin previous to surgery.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

203 participants in 2 patient groups, including a placebo group

Clorhexidine
Experimental group
Description:
Vaginal wash with clorhexidine solution
Treatment:
Drug: Clorhexidine
Saline solution
Placebo Comparator group
Description:
Vaginal wash with saline solution
Treatment:
Drug: Saline solution

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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